Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study

Starting soon

Conditions studied: Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes

In brief

Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.

Key facts

Study ID

NCT07682909

Run by

Aesculap AG

People needed

1020

Starts

2026-12-01

Expected to finish

2042-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age ≤ 80 years
• Indication for a total knee replacement with one of the variants
• Written informed consent
• Willingness and mental ability to participate at the long-term follow-up examinations

You may not qualify if…

• Contraindications acc. to the Instructions for Use (IFU)
• Patient age < 18 years
• Known pregnancy
• BMI > 40
• Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic)
• Patients classified as high risk (ASA class >3)
• Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
• Preoperative: aHKA > 190° or aHKA < 170°
• Preoperative: aHKA > 190° or aHKA < 170°[KB1.1][HO1.2][KB1.3][HO1.4]
• Patients held in a custodial setting und - Patients in a relationship of dependence on the sponsor, the clinic or the investigator

Full record on ClinicalTrials.gov

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